Ranolazine and Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01174173
• Date of registration: 23/07/2010
• Prospective Registration: No
• Primary sponsor: Northwestern University
• Public title: Ranolazine and Pulmonary Hypertension
• Scientific title: Effects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial Hypertension
• Date of first enrolment: June 2010
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01174173
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Sanjiv Shah, MD
• Affiliation: Northwestern University

Key inclusion & exclusion criteria

Inclusion criteria:

1. World Health Organization (WHO) Group 1 PAH, defined as a pulmonary hypertension with
mean pulmonary artery pressure > 25 mmHg, pulmonary capillary wedge pressure < 15
mmHg, and pulmonary vascular resistance > 3 Wood units.

2. Right ventricular dysfunction, defined as RV fractional area change < 32% or RV
tricuspid annular plane systolic excursion (TAPSE) < 15 mm.

3. Symptoms of angina or angina equivalent (exertional dyspnea, exertional epigastric
pain, exertional nausea).

4. New York Heart Association functional class II or III symptoms.

5. Stable doses of pulmonary vasodilators (prostacyclins, endothelin receptor
antagonists, phosphodiesterase inhibitors), with no new therapy initiation or dose
escalation > 50% in the 4 weeks prior to randomization.

6. Age 18-80 years.

Exclusion criteria:

1. Acute coronary syndrome or coronary revascularization within the prior 3 months.

2. Patients with unstable angina.

3. Patients with Class IV congestive heart failure.

4. Planned revascularization, pacemaker or defibrillator placement during the study
period.

5. Changes in antianginal medical therapy likely to occur during the study period.

6. Corrected QT interval measurement >500 ms.

7. Patients with pre-existing QT prolongation (including congenital long QT syndrome) or
receiving other QT prolonging drugs (including Class Ia-e.g., quinidine, Class
III-e.g., dofetilide, sotalol, antiarrhythmics; antipsychotics (e.g., thioridazine,
ziprasidone), or known history of complex ventricular arrhythmias requiring
antiarrhythmic medications or ICD implantation.

8. Patients with known history of hepatic dysfunction.

9. Current use of strong CYP3A inhibitors, including ketoconazole, itraconazole,
clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir and
diltizaem.

10. Patients with pacemakers, cochlear implants, aneurysm clips, who have worked with
metal.

11. Patients with metallic hardware, implants, or prostheses will consult with the
radiologist/cardiologist prior to the study.

12. Patients with severe or end stage renal disease (an estimated GFR < 30 mL/min/1.73 m).

13. Women who are pregnant or lactating

14. Any contraindications for the use of a right heart catheter including, but not limited
to:

- Pulmonic or tricuspid valve stenosis

- Prosthetic pulmonic or tricuspid valve

- Right atrial or ventricular masses

- Previous pneumonectomy

- Risk of severe arrhythmias, including left bundle branch block (LBBB)

15. Subjects unable to perform cardiopulmonary exercise testing will be excluded (i.e.
extensive musculoskeletal disease)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Angina

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Ranolazine

Primary Outcome(s)

6-Minute Walk Test [Time Frame: 3 Months]

Improve Angina Symptoms [Time Frame: 3 months]

Improve Quality of Life [Time Frame: 3 Months]

Secondary Outcome(s)

Right Ventricular Hemodynamics [Time Frame: 3 months]

Absolute RV Longitudinal Strain [Time Frame: 3 months]

RV Perfusion on Cardiac MRI [Time Frame: 3 months]

Secondary ID(s)

STU00030314

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences

Results

• Results available: Yes
• Date Posted: 23/04/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01174173